Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy

Phase 3

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Behavioral: DiaNe consultation and support program

• Registration Number: NCT00782847
• Lead Sponsor: DiaNe HCM GmbH

Brief Summary

This study is designated to evaluate the effect of a patients' educational program called DiaNe® for consultation and support people with diabetic kidney disease in an early stage. The aim of the study is to examine if the program is suitable to stop deterioration of kidney function and to maintain or improve glycemic control. The consultation and support program DiaNe® substantially contributes to a better understanding of the affected clients for this complex clinical picture, allows them for specific interventions and creates the rationale for an active therapeutic relationship.

Detailed Description

According to statistics diabetes mellitus is considered to be the leading cause for end stage renal disease in Germany, approximately 35% of the patients starting on dialysis are affected by diabetes-induced nephropathy. This can be seen in countries all over the world. This situation has been known for years. To date, neither structured intervention methods nor educational programs have been designed for and targeting those affected, which would consequently allow for structured, multifactorial intervention at an early stage of diabetic nephropathy. Multifactorial interventions, as published in the Steno-2 trial, appear to be highly effective with regard to long-term complications of diabetes. In order to realize this approach for the affected as well as the medical staff caring for patients with diabetes-induced nephropathy we developed DiaNe®, a consultation and support program, which is designed to give detailed information to the affected in order to induce behavioral changes. We were able to show a clinically significant reduction of microalbuminuria within a first monocenter evaluation trial. We wanted to verify this effect by means of a prospective multicenter randomized cohort trial according to GCP-ICH guidelines.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2008-10
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Last Update Submitted: 2008-10-30
• Study First Posted: 2008-10-31
• Last Update Posted: 2008-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• diabetes mellitus
• proven diabetic nephropathy by histological/lab findings and/or discretion of nephrologist
• ability to understand the German language

Exclusion Criteria

• end stage renal disease and/or dialysis
• unable or unwilling to follow the protocol
• pregnant women
• discretion of nephrologist

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with DiaNe program	DiaNe consultation and support program	study subjects which participated in the DiaNe consultation and support program

Primary Outcome Measures

Name	Time	Method
deterioration of kidney function in diabetic nephropathy	13 months

Secondary Outcome Measures

Name	Time	Method
HbA1c	13 months

Trial Locations

Locations (1)

Diabetes- und Nierenzentrum Dormagen; 🇩🇪 Dormagen, NRW, Germany